Study of BGB324 in Combination with Pembrolizumab in Patients with Previously Treated Advanced Adenocarcinoma of the Lung.
- Conditions
- Previously Treated Advanced Adenocarcinoma of the LungMedDRA version: 20.0Level: LLTClassification code 10001160Term: Adenocarcinoma lungSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-003609-32-GB
- Lead Sponsor
- BerGenBio ASA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 106
1.Provision of signed informed consent.
2.Male and non-pregnant females aged 18 years or older
3.Histopathologically or cytologically documented Stage IV adenocarcinoma non-small cell lung cancer (NSCLC). Note: Patients with a mixed histology inc a significant area of adenocarcinoma histology are eligible.
4.Cohort A: Has disease progression on or after a prior platinum containing chemotherapy.
Cohort B: a) Has received a maximum of one prior line of anti-PD (L)1 therapy (as monotherapy).
b) Must have had disease control containing at least 2 doses of an anti-PD-(L)1 therapy.
c) Has disease progression when entering screening (first date of progression of disease is taken as end date of response to previous anti-PD-(L)1 therapy) and must be within 12 weeks of last dose of most recent treatment containing an anti-PD-(L)1 therapy.
Cohort C: a) Has received a maximum of one prior line of anti-PD(L)1 therapy in combination with a platinum-containing chemotherapy.
b) Must have had disease control containing at least 2 doses of anti-PD-(L)1 therapy.
c) Has disease progression when entering screening (first date of progression of disease is taken as end date of response to previous anti-PD-(L)1 therapy) and must be within 12 weeks of last dose of treatment containing an anti-PD-(L)1 therapy.
5.Measurable disease as defined by RECIST 1.12 on CT or MRI and as determined by the site study team. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
6.Provision of suitable tumor tissue for the analysis of Axl kinase expression and PD-L1 expression. Suitable tumor tissue must consist of a minimum of newly acquired (fresh) tumor tissue sample (as a FFPE block), together with either further newly acquired tumor tissue (i.e. further FFPE block) or an archival tumor tissue sample (as a further FFPE block or further 10 unstained slides).
7.Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1 [Appendix A].
8.Life expectancy of at least 3 months.
9.Adequate organ function confirmed at Screening within 10 days of treatment initiation - as evidenced by:
a. Platelet count =100,000 /mm3; b. Hemoglobin =9.0 g/dL (=5.6 mmol/L); c. Absolute neutrophil count (ANC) >1,500 /mm3; d. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 times the upper limit of normal (ULN), or =5 times the ULN for patients with liver metastases; e. Total bilirubin =1.5 times the ULN. f. Creatinine =1.5 times the ULN or calculated creatinine clearance 60 mL/min (by Cockcroft Gault formula; see Appendix B);
g.International Normalized Ratio (INR) or Prothrombin Time (PT) =1.5 times the ULN and Activated Partial Thromboplastin Time (aPTT) =1.5 times the ULN. Note: If patient is receiving anticoagulant therapy, then PT or Partial thromboplastin time (PTT) must be within therapeutic range of intended use of anticoagulants;
10.Female patients of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to the first dose of study treatment.
11.Patients (both male and female) of reproductive potential must be willing to practice highly effective methods of contraception (as described in Section 6.14) throughout the study and for 120 days after the last dose of study medication.
12.Have resolution of toxic effect(s) of the most recent prior cancer therapy to Grade 1 or less (except alopecia). If the patient received major surgery o
1. Has disease suitable for local therapy administered with curative intent.
2. Has received more than one prior line of chemotherapy for advanced or metastatic adenocarcinoma of the lung.
3. Cohort A: Has received prior therapy with an immunomodulatory agent; Cohort B: Has received prior chemotherapy alone or in combination with immunotherapy in the metastatic setting.
4. Has a known additional malignancy that is progressing or requires active treatment.
5. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
6. History of cardiac conditions as described in the protocol.
7. Abnormal left ventricular ejection fraction on echocardiography or MUGA (less than the lower limit of normal for a patient of that age at the treating institution or <45%, whichever is lower).
8. Current treatment with any agent known to cause Torsades de Pointes which cannot be discontinued at least five half-lives or two weeks prior to the first dose of study treatment.
9. Screening 12-lead ECG with a measurable QTc interval according to Fridericia’s correction >450 ms.
10. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study treatment.
11. Has participated in a study involving any immune check point inhibitor other than currently approved immune check point inhibitors for their lung cancer.
12. Received chemotherapy or targeted small molecule therapy or radiation therapy within 2 weeks prior to starting study treatment or who has not recovered (i.e. =Grade 1 at baseline) from AEs due to a previously administered agent.
13. Received an anti-cancer monoclonal antibody (mAb) within 4 weeks prior to the first dose of study treatment or who has not recovered (i.e. =Grade 1 or baseline) from AEs due to agents administered more than 4 weeks earlier.
14. Major surgery within 28 days prior to start of study treatment and failure to have recovered adequately from the toxicity and/or complications from the intervention prior to the first dose of study treatment.
15. Received transfusion of blood products or administration of colony stimulating factors within 4 weeks prior to the first dose of study treatment.
16. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
17. Active autoimmune disease that has required systemic treatment in past 2 years
18. Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
19. Has known active infection with Hepatitis B or Hepatitis C.
20. Has received a live-virus vaccination within 30 days of planned treatment start.
21. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
22. Has a history of interstitial lung disease.
23. Inability to swallow or tolerate oral medication.
24. Existing gastrointestinal disease affecting drug absorption such as celiac disease or Crohn’s disease, or previous bowel resection which is considered to be clinically significant or could interfere with absorption.
25. Known lactose intolerance.
26. Requires vitamin K antagonists.
27. Treatment with any of the following: histamine receptor 2 inhibitors, proton pump inhibitors or antacids within 7 days of start of study treatment.
28. Treatment with any medication which is pr
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method